The invention relates to an adaptive device for automated adaptation of the stomach opening of a patient, comprising a gastric band having a non-elastic back part and a first expandable chamber, and a second expandable chamber connected to the first expandable chamber. The invention relates in particular to an adaptive device for automated adaptation of the stomach opening of a patient in which the gastric band is placeable around the stomach of the patient for adaptation of the stomach opening of the patient, and the fluid is displaceable from the one expandable chamber into the other expandable chamber by means of a conveyance device.
Pathological obesity or adiposity is a bigger and bigger problem in today's modern society. Pathologically obese patients tend toward various so-called sequelae, of which in particular cardiovascular diseases such as high blood pressure, metabolic disturbances such as diabetes or gout, and psychic disorders such as depressions, but also excessive wear and tear of the joint cartilage or elevated cerebral stroke risk play an important role. In this connection, pathological obesity also has an extremely negative effect on the national economy of countries since the expenditures relating both to the direct costs (for doctors' treatment and stationary treatment as well as for the corresponding drugs) as well as to the indirect costs (costs for treatment of the secondary diseases) of the obesity amount in certain countries to almost 10% of the overall costs of the health care system.
Various surgical procedures are known which are used for treatment of pathological obesity. Thus, for example, during a so-called operative bypass, a direct connection is made between the stomach and the small intestine. In this case, a portion of the ingested food does not pass through the whole digestive tract, so that its processing in the body is also to a much lower degree. In another surgical procedure, vertical or horizontal sutures or clamps are put in the stomach wall so that the volume of the stomach is reduced, whereby the quantity or respectively the speed of passage of the ingested food is decreased. The drawbacks of these surgical procedures are that they involve complete operative interventions in the tissue of the patient, which can be very traumatizing for the patient. Moreover it is not rare for complications to arise during such surgical interventions, both before as well as during and after the operation, so that the health of the patient can deteriorate even further.
In another procedure, an inflatable balloon (as a rule made of soft synthetic material) is introduced inside the stomach of the patient. The balloon can thereby be introduced into the stomach of the patient either operatively or without surgical intervention in the compact, unfilled state through the mouth. After the balloon has been inserted in the stomach of the patient, it can be filled with a sterile saline solution through a small inflating hose attached to the balloon. This hose is removed after the filling. The presence of an inflated balloon in the stomach gives the patient a constant feeling of being full, so that ingestion of food takes place less frequently. However, this procedure also has significant drawbacks because the constant contact of the balloon of synthetic material with the inner walls of the stomach can lead to gastric ulcers, intestinal occlusions, or inflammations of the gastric mucous membrane. The balloon can also burst in the stomach of the patient, which is connected with at least considerable discomfort for the patient.
Laparoscopic gastric banding is a further method to combat obesity, in which a flexible band of soft synthetic material (usually silicon) is installed in the upper part of the stomach around the stomach of the patient, so that the stomach is completely wrapped around by the band. The gastric band contains a chamber, which can expand through the addition of fluid, whereby the inner diameter of the gastric band is constricted. On the other hand, the inner diameter of the gastric band can also be enlarged through removal of the fluid from the expandable chamber. To this end, a hose connects the flexible gastric band to a fluid container (also called port chamber or port reservoir), which is installed beneath the skin at an easily accessible place. The advantage of laparoscopic gastric banding is that the patient feels full already after a minimal quantity of food, and is not able to eat further. Moreover the prevalent laparoscopic implantation of the gastric band causes significantly less traumatization of the patient compared with conventional surgical procedures. However, this method also has one significant drawback, namely that the stomach opening of the patient cannot be precisely controlled. Above and beyond this, for adaptation of the stomach opening of the patient, an external intervention must be carried out for addition or removal of fluid (usually through a needle). For this reason, the adaptation of the stomach opening of the patient must performed in each case exclusively by specialized personnel (physicians). It is thus clear that the adaptation of the stomach opening cannot be carried out at any desired time, on the one hand, and, on the other hand, at any desired place. Also the gastric band cannot be adapted to the momentary needs of the patient.
Therefore devices have already been put forward that enable a regulation of the quantity of fluid in a gastric band without external intervention. Such a device is described in the document WO 00/09049, for example. Besides the gastric band with an expandable chamber, this device also comprises a container and a hydraulic means, by means of which the fluid can be shifted out of the container into the gastric band and vice versa. In particular the hydraulic means are designed in such a way that the walls of the container can be shifted to change the volume. However, the hydraulic means in this device must be controlled manually or via a remote control. A registration of the position of the body of the patient or of the pressure on the inner wall of the esophagus of the patient and the dynamic adaptation of the stomach opening based on these variables is therefore not possible.
It is desirable to propose a new device and a new method for automated adaptation of the stomach opening of a patient, which does not have the drawbacks of the state of the art. It is in particular desirable to provide an adaptive device and an adaptive method which make possible a precise, flexible, and simple, completely automated change in the stomach opening of the patient without requiring external intervention, the patient not being able to deliberately influence this change.
In accordance with an aspect of the invention an adaptive device for automated adaptation of the stomach opening of a patient is provided, comprising a gastric band with a non-elastic back part and a first expandable chamber, and a second expandable chamber connected to the first expandable chamber, the gastric band being placeable around the stomach of the patient for adaptation of the stomach opening of the patient, and the fluid being displaceable from the one expandable chamber into the other expandable chamber by means of a conveyance device, a switching device with a sensor module is provided for activation of the conveyance device, a measurement value being able to be registered by means of the sensor module, and the switching device being controllable in an automated way based on the change in the measurement value, a switching device with a sensor module being provided for activation of the conveyance device, a measurement value being able to be registered by means of the sensor module, and the switching device being controllable in an automated way based on the change in the measurement value, the change in the position of the body of the patient or the change in the pressure on the inner wall of the esophagus of the patient being able to be registered by means of the sensor module.
The advantage of such an adaptive device is in particular that the adaptation of the stomach opening of a patient may be carried out in a fully automated way. This adaptation can thereby also take place without outside intervention of any kind. On the one hand, in such an adaptive device, the overall quantity of fluid in the closed system is not changed, which is not the case with the conventional devices. On the other hand, any desired type of control can be built in, so that the quality of life of the patient can be significantly improved without the desired effects in relation to an efficient combating of the morbid obesity being reduced <or> eliminated. Furthermore the automated adaptation of the stomach opening of the patient in such an adaptive device can be controlled merely through the change in the body position of the patient and/or the change in the pressure on the inner wall of the esophagus of the patient (owing to the food located therein). In particular this embodiment variant allows an adaptation of the stomach opening of the patient based on whether the patient is standing up or sitting or lying. Thus the stomach opening of the patient can be somewhat enlarged, for example, during a change from sitting position to lying position. The remains of food still located in the esophagus can thereby be conveyed somewhat more easily into the stomach. This is especially advantageous in the evening and during the night since the patient is thereby able to get much better sleep. Differently, the stomach opening of the patient can be decreased again with change from lying position to sitting or standing position (e.g. in the morning when getting up out of bed), whereby food intake again becomes somewhat more difficult. On the other hand, with excessive pressure on the inner wall of the esophagus of the patient, the patient's stomach opening can be quickly opened a little, whereby the food congestion can be relieved more quickly. The stomach opening can then be likewise narrowed again just as quickly and in just as uncomplicated a manner as soon as the pressure on the inner wall of the esophagus of the patient sinks below a predetermined value. Many known difficulties and problems with food congestion in the esophagus and the upper stomach section with conventional devices can be overcome in an especially advantageous way with this embodiment variant.
In a further embodiment variant, the conveyance device is driven mechanically and/or electrically. This embodiment variant has the advantage, among others, that, with different types of drives, an optimal solution and one adapted to the individual needs of each patient can be sought. The mechanical drive has in particular the advantage that dependence on the power supply can be avoided. By means of a combined mechanical-electrical drive, the adaptive device can moreover be operated in an especially simple way. A purely electrical drive is basically less susceptible to possible malfunctions or failures, whereby a higher degree of reliability of the adaptive for adaptation of the stomach opening of the patient may be achieved.
In another embodiment variant, the conveyance device is designed as a hydraulic pump. This embodiment variant has the advantage, among others, that the fluid between the one expandable chamber and the other expandable chamber can be shifted in an especially advantageous and secure way. Miniaturized hydraulic pumps also exist today, so that the overall size or respectively the overall weight of the adaptive device is not enlarged excessively compared with the conventional devices.
In another embodiment variant, the adaptive device comprises a power storage device for drive of the conveyance device, the conveyance device being electrically connected to the power storage device. This embodiment variant has in particular the advantage that power supply of the conveyance device can take place locally. Thus no external power sources are needed that would make the entire device unusable in the event of a blackout. This embodiment variant can therefore be implemented in an especially advantageous way for adaptation of the stomach opening of the patient.
In still another embodiment variant, the power storage device is rechargeable. This embodiment variant has the advantage, among others, that the power storage device does not need to be replaced after each complete emptying. Depending upon the circumstances, the recharging of the power storage device can also be achieved in contactless ways. Thus through this embodiment variant, not only is the handling of the adaptive device for adaptation of the stomach opening of the patient considerably simplified, but its operational costs are also reduced many times over.
In still another embodiment variant, the adaptive device comprises a line for connection of the first expandable chamber to the second expandable chamber. This embodiment variant has in particular the advantage that the two expandable chambers do not necessarily have to be installed close to each other. In particular it is possible for one of the two expandable chambers not to be a component of the gastric band, but instead to be designed as a discrete unit. By means of a line, the two chambers can then be connected to each other, whereby the necessary communication may be established. Through this embodiment variant, conventional devices for adaptation of the stomach opening of the patient can be converted with relatively minimal changes into adaptive devices according to the invention for adaptation of the stomach opening of the patient, further cost savings being thereby achievable.
In another embodiment variant, the line comprises a valve, the valve being controllable by the switching device. This embodiment variant has in particular the advantage that the shift of the fluid out of the one expandable chamber into the other expandable chamber cannot take place without explicit supervision. Thereby achieved is that the stomach opening is not adapted accidentally, which would cause complications for the patient. The valve can also be designed in particular as a fine adjustment valve, whereby the quantity of fluid that is shifted between the two expandable chambers can be especially precisely controlled. Through a lasting deactivation of the valve, a shift of the fluid between the two expandable chambers can also be made completely impossible, whereby the adaptive device according to this embodiment variant can also be used as a conventional device.
In an again different embodiment variant, a delay module is provided by means of which the activation of the switching device is controllable. The advantage of this embodiment variant lies in particular in that the automated adaptation of the stomach opening of the patient cannot be simply triggered by the patient in that this patient deliberately assumes a lying position for a short time. The delay module according to the invention ensures that the automated change of the stomach opening of the patient does not begin until after a certain time, so that the therapeutic advantages of the adaptive device are in no way affected. Suitable as delay modules are all devices or apparatus that can be implanted in the body of the patient.
In a further embodiment variant, the delay module is programmable. The advantage of this embodiment variant is, among others, that the delay can be set differently for each patient, according to need. Of course, for certain patients, it is necessary to select the delay to be relatively long because they have sleeping problems, thus a premature opening would not be in the interest of the treatment. On the other hand, with certain patients, it is necessary to make the delay as short as possible since they rely on a quick opening, or respectively closing, of the stomach opening. Such a programmable delay module thus makes possible a very simple and reliable individualization and personalization of the adaptive device for automatic adaptation of the stomach opening of the patient.
In a still further embodiment variant, the delay module is programmable and/or controllable by means of a remote control. This embodiment variant has the advantage, among others, that the programming of the delay module (and with it also the length of the delay in the automated adaptation of the stomach opening of the patient) can also be carried out externally without intervention in the body of the patient being necessary therefor. In particular, a continuous improvement of the patient can thereby be accommodated.
In still another embodiment variant, the adaptive device is made substantially of synthetic material. This embodiment variant has the advantage, among others, that the synthetic material has especially advantageous characteristics apparent in particular during the implantation and subsequent functioning of the adaptive device for adaptation of the stomach opening of the patient. Particularly suitable synthetic materials are silicon and silicon elastomers, which have already been successfully used for many other implantable devices.
It should be stated here that, besides the adaptive device according to the invention, the present invention also relates to a corresponding adaptive method for automated adaptation of the stomach opening of the patient.